FDA grants 510(k) clearance to Yōni.Fit Bladder Support for SUI

The FDA has granted 510(k) clearance to Yōni.Fit Bladder Support, a vaginal insert for adult patients with urine leakage due to stress urinary incontinence (SUI), announced Watkins-Conti Products, the developer of the device, in a news release.¹

The FDA clearance was supported by findings from a randomized, controlled study of the Yōni.Fit device vs a comparator device.

"I believe Yōni.Fit will be an appealing and effective self-care solution for patients who value convenience and want to be in control of their pelvic health," said Kate C. Arnold, MD, Chief Medical Officer of Watkins-Conti, in the news release.¹ "We are committed to helping all women, including those in rural areas and in medically underserved communities, where access to surgery would be challenging.”

“With this FDA clearance, Watkins-Conti is now positioned to help this important and underserved market," added Ross Watkins, president of Watkins-Conti.¹

Yōni.Fit is a soft vaginal insert intended to reduce urine leakage due to SUI without interfering with voluntary urination. The device is self-administered and can be used during activity or for up to 12 hours for general symptom control.

The FDA clearance of the device was supported by findings from a randomized, controlled study (NCT03978741) that evaluated the efficacy, user acceptance, safety, and tolerability of the Yōni.Fit device vs a comparator device for the temporary management of SUI.

Overall, data from the study showed that a significantly higher percentage of patients experienced a clinically meaningful reduction in 12-hour pad weights with the Yoni.Fit device than with the comparator device (53.0% vs 23.3%; P = .013; absolute difference, 29.6%; 95% CI, 7.4% to 51.8%).²

The percent change in SUI episodes was also higher among those in the Yōni.Fit arm compared with the comparator arm (P < .001). Additionally, 96.3% of patients in the treatment arm experienced a greater than 50% reduction in SUI episodes from baseline, compared with 27.2% of patients in the control arm (P < .001).

More patients who received treatment with the Yōni.Fit device felt that their status was much improved or better vs those who received treatment with a comparator device (P = .001). Those who used the Yōni.Fit device scored higher on the USE Questionnaire subdomain of usefulness.

Further, data regarding safety showed that no patients who received treatment with the Yōni.Fit device experienced any device-related serious adverse events (AEs). Overall, 54.8% of patients who received the Yoni.Fit device experienced an AE during fitting and treatment compared with 29.6% among those who received a comparator device. All AEs reported were of mild to moderate intensity. The most common AE was vaginal discomfort, which was reported in 9 patients in the treatment arm and 5 patients in the control arm.

In total, the single-blind study enrolled 58 adult women with SUI through clinical trials sites at Stanford, NYU Langone Health, and Jefferson Health.

To be included in the trial, patients must have had a BMI lower than 35 and SUI as determined through the cough supine test and at least a 3-month history of experiencing SUI symptoms.³ Further, women of childbearing potential needed to agree to acceptable forms of contraception for the duration of the study.

The primary outcome measure for the study was the responder rate at day 21, defined as at least a 50% reduction in 12-hour pad weight test from the assessment phase (last 7 days of a 14-day period) compared with the 7-day baseline phase. Secondary outcome measures included the percent change in mean pad weight, the percent change in the frequency of SUI events per the patient diary, and the responder rate for the frequency of SUI events per the patient diary at day 21.

Allison L. Watkins, founder and CEO of Watkins-Conti, added in the news release on the FDA clearance,¹ "My lived experience as a new mother with SUI gave me the inspiration for Yōni.Fit. The options available to me at the time did not complement my lifestyle as a working mom with 2 small children. Listening to patients on their journey and innovating accordingly is paramount. I am committed to developing even more solutions for women's pelvic health, using the Yōni.Fit device as a self-care platform that could potentially include diagnostics and drug delivery."

References

1. Women’s healthcare company Watkins-Conti receives FDA 510(k) clearance for new stress urinary incontinence device Yoni-Fit. News release. Watkins-Conti Products, Inc. May 17, 2024. Accessed May 20, 2024. https://www.prnewswire.com/news-releases/womens-healthcare-company-watkins-conti-receives-fda-510k-clearance-for-new-stress-urinary-incontinence-device-ynifit-302149332.html

2. Randomized Controlled Trial Evaluating Efficacy & Safety of a Novel Stress Incontinence Device. Presented at: PFD Week 2023. October 4-6. Portland, Oregon

3. Study evaluating the efficacy and safety of Yoni.Fit in women with stress urinary incontinence. ClinicalTrials.gov. Last updated May 8, 2023. Accessed May 20, 2024. https://clinicaltrials.gov/study/NCT03978741